A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)

This study has been completed.

Sponsor:

Avid Radiopharmaceuticals

ClinicalTrials.gov Identifier:

NCT01503944

First Posted: January 4, 2012

Last Update Posted: August 14, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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The purpose of this study is to evaluate the ability to identify individuals with dopaminergic degeneration in group of patients with a clinical diagnosis of either dementia with Lewy bodies (DLB) or idiopathic Parkinson's disease and to differentiate them from Alzheimer's disease (AD) and control subjects.

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Ages Eligible for Study:

50 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria DLB:

Male or female > 50 years of age

Meet the diagnostic criteria for probable DLB as established by the DLB Consortium (McKeith et al., 2005)

Inclusion Criteria AD:

Male or female > 50 years of age

Meet the NINCDS criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive

Inclusion Criteria PD:

Male or female > 50 years of age

Have probable PD according to the following criteria (Gelb et al., 1999):

Presence of 2 of the following 3 features: rest tremor, rigidity, bradykinesia;

Documented history of a sustained (>6 months) improvement to Levodopa (L-DOPA) or a dopamine agonist

Absence of atypical clinical features or other possible signs or symptoms suggesting another cause of parkinsonism such as a history of frequent falls as a prominent early feature, localized brain lesion(s) or neuroleptic use

Asymmetric onset

A diagnosis of PD made within the 4 years prior to enrollment

Normal subjects:

Are males or females > 50 years of age

Have a MMSE score > 29, and are cognitively normal on the psychometric test battery at screening

Have no signs or symptoms of clinically meaningful parkinsonism

Exclusion Criteria:

Have a history or current diagnosis of other neurologic disease

Have evidence of clinically significant cerebrovascular disease

Have evidence from MRI or other biomarker studies that suggests the presence of a CNS pathology other than that associated with the study diseases

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01503944